UDI Deadline For Class III Medical Devices Quickly Approaching

There is a lot of angst in the pharma community right now about the fast approaching DSCSA first deadline for the exchange of transaction data, but the medical device community is dealing with an even earlier deadline: the September 24, 2014 deadline for UDI on class III medical devices.

The FDA UDI web page lists the following requirements for the September deadline, now less than five months away:

A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.

Class III stand-alone software must provide its UDI as required by § 801.50(b).

Manufacturers or labelers should be well on their way toward meeting these requirements by now. If not, then be aware of that June 23, 2014 deadline to submit a request for that 1-year extension—but be prepared to supply a good reason.

The steps class III device makers or labelers should take include:

1) Select one of the three FDA-accredited identifier issuing agencies: GS1 US, HIBCC or ICCBBA. Your selection may depend on several things of your own choosing, including which one of these you may already be using for all or some of your products;

2) Apply for the necessary base number from your chosen issuing agency. For GS1 US this would be their Global Company Prefix (GCP), for HIBCC it would be their Labeler Identification Code (LIC), and for ICCBBA it would be your Facility ID Number (FIN);

If you plan to attend, use the “promotion code” “RX” to get a special $100 RxTrace discount off the registration price. The promotion code will also work for the UDI Conference in October, but that will be too late for class III device makers who have not been granted an extension.

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About The Author

Dirk is the founder of RxTrace where he writes regularly on the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has written hundreds of essays on those specific topics. A logical thinker, Dirk is skilled at making complex technical topics understandable to non-technical readers and listeners.

An Electrical and Computer Engineer by education, Dirk has worked as a consultant, software architect and automation engineer during a career spanning 30 years. Overall, Dirk's thought leadership has helped to expose hidden complexities and reveal surprising consequences and implications of drug serialization and pedigree laws around the world.

DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counseland trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicatingthe positions of any company, organization or individual other than Dirk Rodgers.